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Class I Recall For GE Healthcare CARESCAPE Ventilator

 
• By Brian Bossetta

The US FDA has designated GE Healthcare’s recall of its CARESCAPE R860 ventilator as Class I, the agency’s most serious category.  

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• Source: Shutterstock

The US Food and Drug Administration has labeled GE Healthcare’s recall of its CARESCAPE ventilator as Class I. GE Healthcare recalled the device because the backup and replacement batteries for the device may fail prematurely posing serious risk and potential death to the user.

The recall, according to the FDA’s 28 June notice, covers 4,222 devices that were distributed in the US between 2 April 2019 and 18 April 2022. The recall also...

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